Study Comparing Orteronel Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT01193244
• Date of registration: 31/08/2010
• Primary sponsor: Millennium Pharmaceuticals, Inc.
• Public title: Study Comparing Orteronel Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
• Scientific title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
• Date of first enrolment: May 2010
• Target sample size: 1454
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01193244
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Netherlands, New Zealand, Poland, Singapore, Slovakia, Turkey, United States

Contacts

• Name: Medical Monitor
• Affiliation: Millennium Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria:

- Voluntary written consent

- Male patients 18 years or older

- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma

- Radiograph-documented metastatic disease

- Progressive disease

- Prior surgical castration or concurrent use of an agent for medical castration

- Either absence of pain or pain not requiring use of any opioid or narcotic analgesia
in the 2 weeks prior to study entry

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Even if surgically sterilized, patients must practice effective barrier contraception
during the entire study treatment and for 4 months after the last dose of study drug,
OR abstain from heterosexual intercourse

- Meet screening laboratory values as specified in protocol

- Stable medical condition

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the
study:

- Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone
(GnRH) analogue

- Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone

- Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all
others prior to first dose of study drug

- Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days
within 3 months prior to study

- Received prior chemotherapy for prostate cancer with exception of
neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease
that was completed 2 or more years prior to screening

- Exposure to radioisotope therapy within 4 weeks of receiving first dose of study
drug; exposure to external beam radiation within 2 weeks of start of screening until
receiving the first dose of study drug

- Documented central nervous system metastases

- Treatment with any investigational compound within 30 days prior to first dose of
study drug

- Current spinal cord compression, bilateral hydronephrosis or current bladder neck
outlet obstruction

- Diagnosis or treatment of another malignancy within 2 years preceding first dose of
study drug except nonmelanoma skin cancer or in situ malignancy completely resected

- Uncontrolled cardiovascular condition as specified in study protocol

- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C

- Unwilling or unable to comply with protocol

- Uncontrolled nausea, vomiting or diarrhea

- Known gastrointestinal disease or procedure that could interfere with oral absorption
or tolerance of orteronel



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: Orteronel + prednisone

Drug: Placebo + prednisone

Primary Outcome(s)

Overall survival (OS) [Time Frame: Time from date of patient randomization to the date of patient death due to any cause]

Radiographic progression-free survival (rPFS) [Time Frame: Day 1 to radiographic disease progression or death]

Secondary Outcome(s)

50% prostate specific antigen (PSA) response at 12 weeks [Time Frame: 12 weeks]

Changes in circulating tumor cell (CTC) counts [Time Frame: 24 weeks]

Time to pain progression [Time Frame: From randomization to the end of treatment]

Secondary ID(s)

2010-018661-35

C21004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors